Post-Approval Studies

Post-Approval Studies

In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).

The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.

CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.

In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

The Focus Group study is a one time study designed to evaluate how easily patients understand the information in the informed decision brochure about the risks associated with the use of slicone breast implants. A total of 35 women participated in one of four group interviewers for the study. Two discussion groups were conducted for women considering breast implants for augmentation and two group interviews were conducted with women considering breast implantssfor reconstruction. Each group was composed of eight to ten women. A trained female moderator led the discussion groups, which were each abouat 2 hours long. Respondents received a $150 honorarium in return for their time. Group interviewrs were conducted in a professional resaraevh facilities that alloesd for observation and audio recording.
The Focus Group study is a one time study designed to evaluate how easily patients

understand the information in the informed decision brochure about the risks associated with the use of slicone breast implants. A total of 35 women participated in one of four group interviewers for the study. Two discussion groups were conducted for women considering breast implants for augmentation and two group interviews were conducted with women considering breast implantssfor reconstruction. Each group was composed of eight to ten women. A trained female moderator led the discussion groups, which were each abouat 2 hours long. Respondents received a $150 honorarium in return for their time. Group interviewrs were conducted in a professional resaraevh facilities that alloesd for observation and audio recording.

Study Population Description

The study population is as per device indication. This device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast Augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the results of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
The study population is as per device indication. This device is indicated for breast augmentation

for women at least 22 years old and for breast reconstruction for women of any age. Breast Augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the results of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.

Sample Size

35 women in one of each of 4 groups. Two were held in Dallas, Texas and two in San Francisco, California. These sites were selected based on the volume of breast implant surgeries condcuted in these areas.
35 women in one of each of 4 groups. Two were held in Dallas, Texas

and two in San Francisco, California. These sites were selected based on the volume of breast implant surgeries condcuted in these areas.

Data Collection

The study used two methods of data collection: discussion groups and a self-administered survey-- to capture both group level and individual level data. A female moderator led each discussion group using a discussion guide prepared in advance by the contracted research firm with the assitance of Mentor Corporation. Two versions of the brochure were tested, one designed for augmentation patients and one designe for reconstruction patients. Endpoints included respondents' reactions to the overall layout oand format of the brochures, content ordering, and iollustrations and tables.. Data were collected on respondents' comprehesnion and perceived relevance of the content. Throughout the discussion, data were gathered on respondents' suggestions for improvements.
The study used two methods of data collection: discussion groups and a self-administered survey-- to

capture both group level and individual level data. A female moderator led each discussion group using a discussion guide prepared in advance by the contracted research firm with the assitance of Mentor Corporation. Two versions of the brochure were tested, one designed for augmentation patients and one designe for reconstruction patients. Endpoints included respondents' reactions to the overall layout oand format of the brochures, content ordering, and iollustrations and tables.. Data were collected on respondents' comprehesnion and perceived relevance of the content. Throughout the discussion, data were gathered on respondents' suggestions for improvements.

Followup Visits and Length of Followup

No Follow-up required

Final Study Results

Actual Number of Patients Enrolled

35 women distributed over 4 groups.

Actual Number of Sites Enrolled

2 (San Francisco and Dallas)

Patient Followup Rate

not applicable

Final Safety Findings

No safety findings. Key findings reported by sponsor are summarized here. Overall reaction to both versions of brochures tested was positive. Group discusions and self-administered survey indicate that solid understanding of the information in brochures. Respondents all agreed that brochure was more comprehensive than anything else they had seen. Respondents had difficulty understanding particular points in the brochure. Misost respondents interpreted the informtion on MRIs for the detection of silent ruptures to mean that MRIs were recommended as replacements for mammography. Many respondents perceived that silicone breast implnats are fragile and prone to rupture. Many were alarmed by this and teh combination of the fact that most ruptures are silent. A few respondents concluded that the true purpose of the brochure was to protect Mentor, rather than inform patietns about breast implant surgery. Respondents reported taht most of the information did not help them weigh the relative importance of risks and complications associated with breast implants. Brochure fell short of provideing infiormation on the benefits of breast implants and did not acknowledge the deeply personal benefits of body image and self-esteem, especially for women who lose their breast to cancer.
No safety findings. Key findings reported by sponsor are summarized here. Overall reaction to both

versions of brochures tested was positive. Group discusions and self-administered survey indicate that solid understanding of the information in brochures. Respondents all agreed that brochure was more comprehensive than anything else they had seen. Respondents had difficulty understanding particular points in the brochure. Misost respondents interpreted the informtion on MRIs for the detection of silent ruptures to mean that MRIs were recommended as replacements for mammography. Many respondents perceived that silicone breast implnats are fragile and prone to rupture. Many were alarmed by this and teh combination of the fact that most ruptures are silent. A few respondents concluded that the true purpose of the brochure was to protect Mentor, rather than inform patietns about breast implant surgery. Respondents reported taht most of the information did not help them weigh the relative importance of risks and complications associated with breast implants. Brochure fell short of provideing infiormation on the benefits of breast implants and did not acknowledge the deeply personal benefits of body image and self-esteem, especially for women who lose their breast to cancer.

Study Strengths and Weaknesses

Discussion groups are useful for exploring attitudes, knowledge and beliefs. Readers should be cautious in intrepreting the data and in making generalizations about the target population as a whole. Given the qualitative nature of the data, they suggest general tendencies but can not be considered definitive. The study is limited by its small sample size and the selection of a non-probablistic sample.
Discussion groups are useful for exploring attitudes, knowledge and beliefs. Readers should be cautious in

intrepreting the data and in making generalizations about the target population as a whole. Given the qualitative nature of the data, they suggest general tendencies but can not be considered definitive. The study is limited by its small sample size and the selection of a non-probablistic sample.

Recommendations for Labeling Changes

Add information clearly describing differences between restoration, replacement, reconstruction, and revision early in the main body of the brochure. add informtion on Organize information on potential complications based onteh likelihood of occurrence and calling attention to the relative importance of each possible outcome. Provide more information about benefits. provie more qualitative information (personal testimony, caes histories) to help women make more informed decisions. Include more illustrations, visual white space, color and bolding. mke illustrations, larger, darker, ,orerealistinc and more clearly labelled.
Add information clearly describing differences between restoration, replacement, reconstruction, and revision early in the main

body of the brochure. add informtion on Organize information on potential complications based onteh likelihood of occurrence and calling attention to the relative importance of each possible outcome. Provide more information about benefits. provie more qualitative information (personal testimony, caes histories) to help women make more informed decisions. Include more illustrations, visual white space, color and bolding. mke illustrations, larger, darker, ,orerealistinc and more clearly labelled.